When taking BRAFTOVI + cetuximab + FOLFIRI, it's important to be aware of the possible side effects. These are grouped into two categories: the most serious potential side effects and the most commonly experienced side effects. It’s important to note that these are not all of the possible side effects of this treatment. Call your doctor for medical advice about side effects.
 

Learn about possible serious side effects OF BRAFTOVI

The possible serious side effects of this treatment are listed below. If you have any of these symptoms, call your doctor immediately. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with BRAFTOVI if you have certain side effects.

triangle with exclamation point representing the potential risk of new cancers

Risk of new skin cancers

Symptoms included new warts; skin sores or reddish bumps that bleed or do not heal; change in size or color of a mole.

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Heart problems, including heart failure

Symptoms included feeling like your heart is pounding or racing; shortness of breath; swelling in your hands, ankles, legs, or feet; feeling faint or light-headed.

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Liver problems

Symptoms included yellowing of your skin or your eyes; dark or brown (tea-colored) urine; nausea or vomiting; loss of appetite; tiredness; bruising; bleeding.

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Bleeding problems

Can lead to death. Symptoms included headaches, dizziness, or feeling weak; coughing up blood or blood clots; vomiting blood or your vomit looks like “coffee grounds”; red or black stools that look like tar; nose bleeds.

eye icon representing the possible side effect of eye problems

Eye problems

Symptoms included blurred vision, loss of vision, or other vision changes; seeing colored dots; seeing halos (blurred outline around objects); eye pain, swelling, or redness.

icon of heart rate line representing the potential side effects of QT prolongation problems

Changes in the electrical activity of your heart (QT prolongation)

Can be life-threatening. Symptoms included feeling faint, light-headed, dizzy, or if you feel your heart beating irregularly or fast.

Icon of triangle and exclamation point representing the potential side effect of risk of harm to unborn babies

Risk of harm to unborn babies

Tell your doctor if you are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.

These are not all of the possible side effects of BRAFTOVI + cetuximab + FOLFIRI.

Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects to Pfizer Inc. at 1-800-438-1985.

The most common side effects

The side effects listed below were the ones most commonly experienced by people taking this treatment. Remember, the information below does not replace directions from your doctor. Always talk to your doctor about side effects and ways you may be able to manage them. Your doctor may change your dose or stop treatment temporarily or completely. Before taking any medicines, speak with your doctor. Click on the arrows below for information about side effects to discuss with your doctor.

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Nausea

Nausea may be worse if your stomach is empty, so discuss your eating habits with your doctor. Ask if they would recommend an anti-nausea medicine.

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Diarrhea

Your doctor may suggest you take over-the-counter anti-diarrheal medicine to help, and it’s also always important to stay hydrated. Sports drinks may help replace electrolytes and salts. Report diarrhea to your doctor right away.

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Fatigue

Talk to your doctor if you experience fatigue (tiredness or lack of energy). Ask if they would recommend daily exercise or other activities that may help reduce fatigue.

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Vomiting

It’s important to stay hydrated throughout treatment. Talk to your doctor about liquids and over-the-counter medicines that may help. Fruit juices (avoid grapefruit juice), ginger ale, water, and sports drinks may also help prevent dehydration.

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Hair loss (alopecia)

Talk to your doctor if you experience hair loss. Ask if they recommend scalp massages to improve blood flow, wearing a soft sleep cap or scarf to reduce irritation, or using sunscreen to protect the skin on your scalp.

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Constipation 

Talk to your doctor if you are experiencing frequent constipation. They may suggest certain over-the-counter medicines or ask you to keep track of your diet and exercise. Ask about including high-fiber foods into your diet, such as cereals or smoothies, and be sure to stay hydrated. Staying active may also help ease constipation.

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Stomach-area (abdominal) pain

Talk to your doctor about your eating habits and how you can make adjustments. Ask if there are certain foods to avoid and whether eating smaller meals throughout the day could help.

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Decreased appetite

Discuss with your doctor different ways you could increase your appetite. Ask about eating balanced, nutritious meals and eating small, frequent meals or snacks 6 to 8 times daily.

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Rash

Tell your doctor about any rashes right away. Ask if they would recommend any soaps, creams, or lotions to soothe it.

BRAFTOVI may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if this is a concern for you.

These are not all of the possible side effects of BRAFTOVI + cetuximab + FOLFIRI.
Call your doctor for medical advice about side effects.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only).
If you prefer, you may contact the US Food and Drug Administration (FDA) directly.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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TAKING THE treatment

Find important tips to remember
when starting and during
treatment.

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IMPORTANT SAFETY
INFORMATION AND USE

FIND OUT MORE

COLLAPSE

What is BRAFTOVI?
  • BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

It is not known if BRAFTOVI is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Important information: BRAFTOVI (encorafenib) is used in combination with other medicines, including cetuximab or cetuximab and fluorouracil-based chemotherapy. Talk to your healthcare provider about cetuximab, cetuximab with mFOLFOX6, or cetuximab with FOLFIRI if used with BRAFTOVI.

BRAFTOVI can cause serious side effects, including:

  • Risk of new skin cancers. BRAFTOVI can cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma. Talk to your healthcare provider about your risk for these cancers.

Check your skin and tell your healthcare provider right away about any skin changes, including a:

    • new wart
    • skin sore or reddish bump that bleeds or does not heal
    • change in size or color of a mole

Your healthcare provider should check your skin before treatment, every 2 months during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment.

  • Heart problems, including heart failure. BRAFTOVI can cause heart problems. Your healthcare provider will check your heart function before and during treatment. Tell your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
    • feeling like your heart is pounding or racing
    • shortness of breath
    • swelling in your hands, ankles, legs, or feet
    • feeling faint or light-headed
  • Liver problems. BRAFTOVI can cause liver problems. Your healthcare provider will perform blood tests to check your liver function before and during treatment. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem:
    • yellowing of your skin or your eyes
    • dark or brown (tea-colored) urine
    • nausea or vomiting
    • loss of appetite
    • tiredness
    • bruising
    • bleeding
  • Bleeding problems. BRAFTOVI can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Tell your healthcare provider and get medical help right away if you develop any signs of bleeding, including:
    • headaches, dizziness, or feeling weak
    • cough up blood or blood clots
    • vomit blood or your vomit looks like “coffee grounds”
    • red or black stools that look like tar
    • nose bleeds
  • Eye problems. BRAFTOVI can cause eye problems. Your healthcare provider should perform an eye exam regularly during treatment. Tell your healthcare provider right away if you develop any new or worsening symptoms of eye problems, including:
    • blurred vision, loss of vision, or other vision changes
    • see colored dots
    • see halos (blurred outline around objects)
    • eye pain, swelling, or redness
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start taking BRAFTOVI and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, light-headed, dizzy, or if you feel your heart beating irregularly or fast during treatment with BRAFTOVI. These symptoms may be related to QT prolongation

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with BRAFTOVI if you have certain side effects.

Tell your healthcare team if you are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.

Females who are able to become pregnant:

  • Should use effective nonhormonal birth control (contraception) during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI
  • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI
  • Your healthcare provider will do a pregnancy test before you start taking BRAFTOVI. Tell your healthcare provider right away if you become pregnant or think you might become pregnant during treatment

Talk to your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if BRAFTOVI passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI.

BRAFTOVI may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

The most common side effects of BRAFTOVI when taken in combination with cetuximab and mFOLFOX6 for colorectal cancer include: numbness, tingling, or burning in your hands or feet (peripheral neuropathy), nausea, fatigue, diarrhea, decreased appetite, rash, vomiting, bleeding (hemorrhage), stomach-area (abdominal) pain, pain or swelling of your joints (arthralgia), fever, and constipation.

The most common side effects of BRAFTOVI when taken in combination with cetuximab and FOLFIRI for colorectal cancer include: nausea, diarrhea, fatigue, vomiting, hair loss (alopecia), constipation, stomach-area (abdominal) pain, decreased appetite, and rash.

Before taking BRAFTOVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have had bleeding problems
  • have eye problems
  • have heart problems, including a condition called long QT syndrome
  • have been told that you have low blood levels of potassium, calcium, or magnesium
  • have liver or kidney problems
  • are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRAFTOVI and certain other medicines can affect each other, causing side effects or affecting how BRAFTOVI or other medicines work. You should also avoid grapefruit products during treatment with BRAFTOVI.

These are not all of the possible side effects of BRAFTOVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects to Pfizer Inc. at 1-800-438-1985.

What is BRAFTOVI?
  • BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

It is not known if BRAFTOVI is safe and effective in children.

Please see BRAFTOVI full Prescribing Information, including Medication Guide, for additional information.

What is BRAFTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):

  • that has spread to other parts of the body, and
  • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

It is not known if BRAFTOVI is safe and effective in children.

What is BRAFTOVI (encorafenib)?

BRAFTOVI is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

It is not known if BRAFTOVI is safe and effective in children.

What is BRAFTOVI (encorafenib) and MEKTOVI (binimetinib)?

BRAFTOVI is a prescription medicine used:

BRAFTOVI should not be used to treat adults with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI or BRAFTOVI with MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

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What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

  • in combination with a prescription medicine called MEKTOVI (binimetinib) to treat adults with a type of skin cancer called melanoma:
    • that has spread to other parts of the body or cannot be removed by surgery, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with a medicine called MEKTOVI (binimetinib) to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI or BRAFTOVI with MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI (encorafenib) + MEKTOVI (binimetinib)?

BRAFTOVI and MEKTOVI are prescription medicines used together to treat adults with a type of skin cancer called melanoma:

BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults with a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI (encorafenib) + MEKTOVI (binimetinib)?

BRAFTOVI and MEKTOVI are prescription medicines used together to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):

BRAFTOVI should not be used to treat people with wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):

  • that has spread to other parts of the body, and
  • that has a certain type of abnormal "BRAF" gene

BRAFTOVI should not be used to treat people wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI with MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.